The discovery of the genetic code by Watson and Crick four decades ago defined the principles by which genes (the genetic code) encode for proteins by determining the sequence of amino acids. As is known, proteins are important carriers of metabolic information in living organisms. Exogenous protein organisms such as the HIV virus, and other endogenous proteins such as that which causes diabetes, are also the cause of many human diseases.
The genetic code determines the structure of proteins, thereby dictating the function of the protein. In the vast majority of proteins, biological activity and the specific function of the protein is primarily mediated via specific amino acid sequences located on the outside surface of the three dimensional protein.
The protein code determines the relation between structure and function within a protein sequence and, thereby effects a specific biological action. Therefore, the protein code is the biological language for protein-mediated information transfer during health and disease. The interaction of hormones and other ligands with their respective receptors, of enzymes with protein substrates, of adhesive proteins with integrins, and of antibodies with antigens, as well as other protein actions and interactions are determined by the same structure/function principles and the same biological language. The protein code also provides a missing link in the regulation of protein synthesis. Proteins also have important feed-back functions directly or indirectly modulating the synthesis rate of that protein. The structure/function relation of proteins, which determines protein actions and interactions, are hereafter referred to as the protein code.
Conventional drug therapy is frequently compromised by an unknown therapeutic mechanism and by a wide range of side effects and considerable toxicity. Conventional gene therapy uses some of the protein interaction principles mentioned above to increase the therapeutic specificity of the pharmaceutical and the delivery of the drug to the target cells and organs, which results in a reduction in toxicity and safety compared to conventional drug therapy. However, gene therapy has its disadvantages as it requires that the specific sequence of the entire disease causing protein be determined. That is, in order to treat or fight a disease, scientists attempt to determine the genetic code by replicating the entire amino acid sequence of the disease causing protein. Gene therapy is compromised by its technological requirements and its high cost. The development of gene therapy drugs is a time consuming process through the research and development phase of the drug, the clinical studies phase, as well as in the drug manufacturing and therapy phase of the drugs so developed. For example, in gene therapy, identification of the target disease causing proteins spans anywhere from months to years. The production of a drug, in-vitro tests, in-vivo tests alone takes approximately another several years. First clinical studies span between 5 to 10 years. This causes drugs developed through gene therapy to be very expensive, and restricts its therapeutic application to only certain more profitable and exclusive areas of diseases in the foreseeable future.
Therefore, there is a need for a method of therapy that allows for the interception of pathological interactions with maximum effectiveness.
There is a further need for a method of therapy that enables maximum therapeutic specificity, based on the precise structure/function relation of specific oligopeptide signals.
Yet another need is for a method of therapy that is safe and eliminates or limits toxicity, and allows for controlling undesired biological side-effects by optimizing the length and composition of the therapeutic peptide.
There is also a need for a therapy method that reduced the time and expense of development of therapeutic peptides to a fraction of conventional gene therapeutic research and development. Most importantly, there is a need for a targeted and safe therapy method which will allow clinical application of drugs for a variety of disease causing proteins that have been ignored because of the cost of development.